510(k) Report

FDA applicant

Micrus Endovascular Corporation

San Jose, CA23 decisions2005–20112 recalls

FDA records 23 decisions for Micrus Endovascular Corporation (San Jose, CA) from 2005 to 2011: 23 510(k) clearances. Most are in product codes HCG (Device, Neurovascular Embolization) and DQO (Catheter, Intravascular, Diagnostic). Its devices cite 45 predicates, 21 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Micrus Endovascular Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2007: 62008: 52009: 52010: 12011: 1
2007high 6 (2007) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Micrus Endovascular Corporation by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Micrus Endovascular Corporation’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • HCGDevice, Neurovascular Embolization11decisions
  • DQOCatheter, Intravascular, Diagnostic6decisions
  • MJNCatheter, Intravascular Occluding, Temporary3decisions
  • DQXWire, Guide, Catheter3decisions

Whose devices does it build on?

Its devices cite 45 predicates; 21 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 38 times; 21 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K060116Micrus Courier MicrocathetersMicrus Endovascular Corporation · 20066cite it
  • K073442Micrus Microcoil SystemsMicrus Endovascular Corporation · 20083cite it
  • K080379Micrus Microcoil System, Deltapaq 10 Stretch ResistantMicrus Endovascular Corporation · 20083cite it
  • K072173Micrus Microcoil System Cashmere-Cerecyte, Model CRC; Cashmere-SR, Model SRCMicrus Endovascular Corporation · 20073cite it
  • K062036Micrus Microcoil System Presidio-18, Model PC4Micrus Endovascular Corporation · 20063cite it
  • K080437Micrus Microcoil System, Deltapaq 10 Cerecyte, Model CDFMicrus Endovascular Corporation · 20083cite it

What has FDA decided for it lately?

  • K103780Micrus Ascent Occlusion Balloon Catheter 4X7 MM; Micrus Ascent Occlusion Balloon Catheter 6X9 MM; Micrus…Micrus Endovascular Corporation · 2011
  • K102818Micrus One 2 One Guidewire, Micrus One 2 One Soft GuidewireMicrus Endovascular Corporation · 2010
  • K092702Micrus Microcatheter, Model Courier 270Micrus Endovascular Corporation · 2009
  • K091504Micrus Ascent Occlusion Balloon Catheter 4X7MM,6X9MM, Micrus Summit Occlusion Balloon Catheter 4X10MM,4X15…Micrus Endovascular Corporation · 2009
  • K083922Micrus Microcatheter, Courier Flex, Model MSF 170000-00Micrus Endovascular Corporation · 2009
  • K090274Micrus One 2 One Guidewire and Soft GuidewireMicrus Endovascular Corporation · 2009
  • K083646Micrus Microcoli System, Deltaplush, Models CPL, DPLMicrus Endovascular Corporation · 20091 recall
  • K082739Micrus Microcoil Delivery SystemMicrus Endovascular Corporation · 2008

All 23 as Micrus Endovascular Corporation →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K062036Micrus Endovascular Microcoil Delivery System; The Micrus Microcoil Delivery System…Oct 21, 2010
  • K053265Micrus brand WATUSI Guidewire 0.014'' - Soft Tip, Catalog Number; WST 140205-00…Sep 8, 2006

Other applicant names beginning “Micrus”

FDA records each applicant name separately; these may or may not be the same firm.

Micrus Corp. 6Micrus Design Technology, Inc. 1